# K936223: Pressure Irrigating System

- Pathway: 510(k) (Traditional)
- Applicant: Level 1 Technologies, Inc.
- Decided: May 12, 1994 after 134 days
- Product code: GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered)
- Device class: 1
- Regulation: 21 CFR 878.4680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 1 cites it directly.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K072080: Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation Warming Set, Models, IR-40, IR-500, IR-600, (2008), 7 descendants of its own
- K091939: Thermedx Prodigy Fluid Management System, Models P1000, P2000 (2010), 4 descendants of its own
- K133799: Thermedx Fluid Managment System (2014), 3 descendants of its own
- K172048: FluidSmart (2017), 2 descendants of its own
- K262532: NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) (2026), 0 descendants of its own

Source page: https://510kreport.com/device/K936223
Methodology: https://510kreport.com/methodology